Efficacy of Combination of Biodentine and Simvastatin as a Pulp Capping Materials in Vital Pulpotomy of Primary Molars: - a Clinical and Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clinical assessment
研究概览
简要总结
Objective: This study was conducted to evaluate the efficacy of combination of biodentine with simvastatin as a pulpotomy agent for vital primary molars clinically and radiographically.
Study design: 60 primary molars in 20 children aged 4-7 years old were randomly allocated to three groups, Biodentine, Simvastatin and combination of Biodentine and simvastatin. Clinical and radiographic examinations were conducted at 1, 3, 6, 9 and 12 months after treatment.
Key words: Pulpotomy, Primary teeth, Biodentine, Simvastatin.
详细描述
Each tooth will be locally anesthetized using topical anesthetic gel benzocaine 20% on the mucosa after drying the area with gauze; the application of local anesthesia using Mepivacaine Hydrocholride 2% with Levonordefrin 1:20000 to the tooth following the recommended technique for each tooth to be treated; then the tooth will be isolated using rubber dam and high suction 3. The pulpotomy procedures will be performed as follow:- All soft caries will be removed by large spoon excavator. Cavity outline will be performed using a sterile #330 carbide bur at high speed (30,000 rpm) contra-angle hand piece will be used under a water coolant.
- Access to a pulp chamber will be detected with a probe, or if the roof of the pulp chamber is sufficiently thin to see the pulpal tissue. When the pulpal exposure is confirmed, the roof of the pulp chamber will be removed with a sterile large low speed round bur #4 with water spray.
- The coronal pulp will be amputated using a sterile sharp spoon excavator, until the orifices of the stumps can be seen clearly without remnant tags and the access will be refined with a sterile high speed fissure bur (El sayed et al., 2019).
- The pulp chamber will be irrigated with normal saline.
- Pulp hemostasis will be achieved using a wet cotton pellet with sterile saline applied on the radicular pulp stumps under slight pressure for 2 to 3 minutes.
- If bleeding cant be controlled within 5 minutes, the tooth will be excluded from the study and the needed treatment will be done.
- Depending on group allocation, the pulp stumps of molars will be dressed as follows:
Group (I): 20 primary molars were treated with Biodentine :-
The mixture of Biodentine will be made according to manufacturer's directions as follow:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Apparently healthy children free from any known systemic diseases.
- •Parent willing to participate in the study and signed an informed consent.
- •Patient had at least three restorable primary molars with a caries- exposed vital pulp
排除标准
- •history of spontaneous pain or provoked pain.
- •clinical signs and ̸ or symptoms suggesting a non-vital tooth such as (fistula, sinus tract, soft tissue swelling, mobility or tenderness to percussion).
- •non-Restorable tooth
- •pathologic or physiologic mobility
研究组 & 干预措施
Biodentine
20 primary molars were treated by Biodentine
干预措施: Biodentine (Drug)
Simvastatin
20 primary molars were treated by Biodentine
干预措施: Simvastatin (Drug)
combination of Biodentine and Simvastatin
20 primary molars were treated by Biodentine
干预措施: Biodentine (Drug)
combination of Biodentine and Simvastatin
20 primary molars were treated by Biodentine
干预措施: Simvastatin (Drug)
结局指标
主要结局
Clinical assessment
时间窗: 12 months
Pain, tenderness, Swelling No tender on percussion. No swelling/sinus. No pathological tooth mobility.
次要结局
- Radiographically:(12 months)